Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update
Details
Publication Year 2024-04-25,Volume 143,Issue #17,Page 1713-1725
Journal Title
Blood
Publication Type
Research article
Abstract
Tisagenlecleucel is approved for adults with relapsed/refractory (r/r) follicular lymphoma (FL) in the third- or later-line setting. The primary analysis (median follow-up, 17 months) of the phase 2 ELARA trial reported high response rates and excellent safety profile in patients with extensively pretreated r/r FL. Here, we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after median follow-up of 29 months (interquartile range, 22.2-37.7). As of 29 March 2022, 97 patients with r/r FL (grades 1-3A) received tisagenlecleucel infusion (0.6 × 108-6 × 108 chimeric antigen receptor-positive viable T cells). Bridging chemotherapy was allowed. Baseline clinical factors, tumor microenvironment, blood soluble factors, and circulating blood cells were correlated with clinical response. Cellular kinetics were assessed by quantitative polymerase chain reaction. Median progression-free survival (PFS), duration of response (DOR), and overall survival (OS) were not reached. Estimated 24-month PFS, DOR, and OS rates in all patients were 57.4% (95% confidence interval [CI], 46.2-67), 66.4% (95% CI, 54.3-76), and 87.7% (95% CI, 78.3-93.2), respectively. Complete response rate and overall response rate were 68.1% (95% CI, 57.7-77.3) and 86.2% (95% CI, 77.5-92.4), respectively. No new safety signals or treatment-related deaths were reported. Low levels of tumor-infiltrating LAG3+CD3+ exhausted T cells and higher baseline levels of naïve CD8+ T cells were associated with improved outcomes. Tisagenlecleucel continued to demonstrate highly durable efficacy and a favorable safety profile in this extended follow-up of 29 months in patients with r/r FL enrolled in ELARA. This trial was registered at www.clinicaltrials.gov as #NCT03568461.
Publisher
American Society of Hematology
Keywords
Humans; *Lymphoma, Follicular/drug therapy/mortality; Middle Aged; Male; Female; Aged; Adult; Immunotherapy, Adoptive/adverse effects/methods; Neoplasm Recurrence, Local/drug therapy; Receptors, Antigen, T-Cell/therapeutic use; Follow-Up Studies; Treatment Outcome
Department(s)
Clinical Haematology
Open Access at Publisher's Site
https://doi.org/10.1182/blood.2023021567
Terms of Use/Rights Notice
Refer to copyright notice on published article.


Creation Date: 2024-07-04 04:51:22
Last Modified: 2024-07-04 04:51:28

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